PSV · Class II · 21 CFR 892.1550

FDA Product Code PSV: Ultrasound Bronchoscope

An Ultrasound Bronchoscope Is Indicated For The Ultrasonic Visualization, Diagnosis And Therapeutic Access To The Bronchial Tree Or The Lungs. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).

Leading manufacturers include Olympus Medical Systems Corporation, Olympus Optical Co., Ltd. and Olympus Medical Systems Corp..

4
Total
4
Cleared
142d
Avg days
2002
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 202d recently vs 122d historically

FDA 510(k) Cleared Ultrasound Bronchoscope Devices (Product Code PSV)

4 devices
1–4 of 4
Cleared Aug 27, 2026
EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)
K260401
Olympus Medical Systems Corporation
Ear, Nose, Throat · 202d
Cleared Sep 06, 2019
EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F
K183525
Olympus Medical Systems Corp.
Ear, Nose, Throat · 261d
Cleared Jul 05, 2007
OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA SSD-ALPHA 5/10 ULTRASOUND SYSTEM
K070983
Olympus Medical Systems Corporation
Radiology · 90d
Cleared May 01, 2002
OLYMPUS BF TYPE UM40
K021204
Olympus Optical Co., Ltd.
Radiology · 15d

About Product Code PSV - Regulatory Context

510(k) Submission Activity

4 total 510(k) submissions under product code PSV since 2002, with 4 receiving FDA clearance (average review time: 142 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - PSV Product Code

Recent submissions under PSV have taken an average of 202 days to reach a decision - up from 122 days historically. Manufacturers should account for longer review timelines in current project planning.

PSV devices are reviewed by the Radiology panel. Browse all Radiology devices →